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Not Yet Recruiting NCT05701748

EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

Conditions: Electroencephalography Spectral Edge Frequency, Anesthetic Depth

Sex: All
Ages: 3 Months – 24 Months
Healthy volunteers: 1
Phase: NA
Enrollment: 75
Sponsor: Children's Hospital of Philadelphia

Summary

The goal of this study is monitor anesthetic depth of children undergoing propofol anesthesia using electroencephalography (EEG). The main questions it aims to answer are:EEG sepctral edge frequency (SEF) readings where 50% of patients do not respond to three stimuli.The propofol blood concentration that corresponds to each of the three EEG SEF readings Participants will undergo EEG monitoring, stimuli (placement of oral pacifier, electrical stimulation, and laryngoscopy), and blood collection.

Eligibility Criteria

Inclusion Criteria:Children 3 to 24 month old undergoing surgery.Planned laryngoscopy and endotracheal intubation for clinical care.Planned propofol anesthesia for anesthesia maintenance.ASA < III.Muscle relaxant not indicated per planned clinical care for laryngoscopy/intubation.Anticipated surgery duration approximately < 2h40minExclusion Criteria:Patients undergoing emergency surgery.Known severe neurological disease which might result in abnormal EEG SEF.Deformities of forehead (difficult EEG sensor placement).Known difficult airway.Allergy to propofol.Attending anesthesiologist on record caring for patient plans to administer additional IV medication besides propofol during study phase.Currently on anti-seizure medication (might alter propofol pharmacodynamics).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05701748). StuddyBuddy aggregates publicly available trial information.